NCT03568331已完成3 期
A Randomized, Double-Blind, Placebo-Controlled Efficacy Study of The Neurokinin-1 Receptor Antagonist VLY-686 in Patients With Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 375
- 试验地点
- 1
- 主要终点
- Reduction of Worst Itch in Atopic Dermatitis
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in the United States in subjects with atopic dermatitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and non-pregnant, non-lactating female patients aged 18 - 70 years (inclusive);
- •Diagnosed with atopic dermatitis;
- •Suffering from chronic pruritus;
- •Body Mass Index (BMI) of ≥18 and ≤40 kg/m2
排除标准
- •Chronic pruritus due to condition other than atopic dermatitis (AD);
- •A positive test for drugs of abuse at the screening or evaluation visits;
- •Exposure to any investigational medication in the past 8 weeks
研究组 & 干预措施
Tradipitant
Experimental
干预措施: Tradipitant (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Reduction of Worst Itch in Atopic Dermatitis
时间窗: 8 weeks
Reduction of worst itch in atopic dermatitis as measured by Numerical Rating Scale (NRS). Worst Itch NRS is an assessment tool that is used to report the maximum intensity of participant's itch during a 24-hour recall period. Participants were asked the following question: Please rate the itching severity that describes your worst level of itching in the past 24 hours \[0=No Itch, 10=Worst Itch Imaginable\].
次要结局
- Proportion of Patients With Improvement on Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of at Least 2-point Reduction(8 weeks)
- Improvement of Disease Severity in Atopic Dermatitis(8 weeks)
研究者
研究点 (1)
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